On December 2, 2024 Rakovina Therapeutics Inc. (TSX-V: RKV, the "Company" or "Rakovina Therapeutics"), a biopharmaceutical company committed to advancing new cancer therapies based on novel DNA-damage response technologies, reported that its previously announced private placement has been further upsized to $3 million, based on strong indications of interest from potential investors in the financing (Press release, Rakovina Therapeutics, DEC 2, 2024, View Source;utm_medium=rss&utm_campaign=rakovina-therapeutics-increases-private-placement-offering-to-3-0-million [SID1234648760]).

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The Offering is structured as units priced at $0.06 each, with each unit consisting of one common share and one warrant to purchase a common share. Each warrant entitles the holder to purchase one additional common share at a price of $0.10 per share, exercisable for a period of 24 months. Rakovina retains the right to accelerate the warrant exercise period if the 20-day volume-weighted average price of its shares exceeds $0.30.

The Company plans to use the proceeds to continue the discovery and advancement of novel cancer treatments by leveraging collaborations with two proprietary Artificial Intelligence (AI) platforms: the Deep Docking AI platform and the Variational AI Enki Platform. The Company also plans to continue the development of its kt-3000 series through collaborations and partnerships with biotech and pharma companies.

The Offering is subject to all necessary regulatory approvals, including acceptance from the TSX Venture Exchange. The Units will be sold on a non-brokered "private placement" basis in accordance with applicable Canadian securities laws and under applicable exemptions from prospectus and registration requirements, and the securities will be subject to resale restrictions for a period of four months plus one day from the date of issue.

On December 2, 2024 Adcentrx Therapeutics ("Adcentrx"), a clinical-stage biotechnology company advancing innovative protein conjugates for cancer and other life-threatening diseases, reported the dosing of the first patient in the Phase 1b portion of ADRX-0706-001, the ongoing Phase 1a/b study of ADRX-0706 for the treatment of advanced solid tumors (Press release, Adcentrx Therapeutics, DEC 2, 2024, View Source [SID1234648710]).

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"We are pleased to advance the clinical development of ADRX-0706 into the Phase 1b dose expansion cohorts," said Hui Li, Ph.D., Founder and Chief Executive Officer of Adcentrx. "Encouraging findings from our Phase 1a trial demonstrate the best-in-class potential for ADRX-0706, with differentiated safety and pharmacokinetic properties, including a much lower incidence of critically meaningful AEs for patients, such as peripheral neuropathy. Additionally, the preliminary efficacy responses observed across different dose levels and tumor types provide important clinical validation of Adcentrx’s ADC platform, including the i-Conjugation technology and novel auristatin payload AP052."

The first-in-human Phase 1a/b study is an open-label, two-part trial being conducted at sites in the U.S. and China. The Phase 1a part consisted of a dose escalation of ADRX-0706 to evaluate initial safety and tolerability in patients with select advanced solid tumors, and to identify the recommended dose to be used in the Phase 1b part. This second portion of the study will continue to assess the safety and tolerability of ADRX-0706, as well as evaluate preliminary efficacy and determine the optimal dose in urothelial cancer, triple-negative breast cancer, and cervical cancer expansion cohorts. The company expects an initial data readout from the Phase 1b in 4Q 2025.

About ADRX-0706

ADRX-0706 is a fully proprietary ADC product candidate discovered by Adcentrx. The antibody component is a novel fully human IgG1 targeting Nectin-4, a cell surface adhesion protein with high expression in multiple solid tumors and limited expression in normal tissues. Nectin-4 is associated with poor disease prognosis and is a validated target for ADCs.

The ADRX-0706 antibody is linked to a proprietary tubulin inhibitor payload, AP052, through Adcentrx’s innovative i-Conjugation technology using a cleavable linker and stable conjugation chemistry. This novel platform technology enables a highly stable ADC with a drug-antibody ratio of eight (DAR 8) with a substantially expanded therapeutic window as demonstrated in preclinical studies.

ADRX-0706 has a favorable pharmacokinetic and safety profile in preclinical models and has demonstrated significant efficacy across a variety of tumor indications in vitro and in vivo. ADRX-0706 is currently being evaluated in a Phase 1a/b clinical trial.

For more information about the ADRX-0706 Phase 1a/b clinical trial, please refer to the Study ID NCT06036121 on ClinicalTrials.gov.

On December 2, 2024 Soligenix, Inc. (Nasdaq: SNGX) (Soligenix or the Company), a late-stage biopharmaceutical company focused on developing and commercializing products to treat rare diseases where there is an unmet medical need, reported that analysis of the post-treatment data from the open-label study (protocol HPN-CTCL-04) comparing HyBryte (synthetic hypericin) to Valchlor (mechlorethamine) has demonstrated continued improvement in HyBryte treated patients and their individual lesions even after stopping treatment (Press release, Soligenix, DEC 2, 2024, View Source [SID1234648727]). The study, which enrolled 10 patients randomized 1:1 with 12 weeks of treatment and 4 weeks of follow-up post-treatment, was previously reported to demonstrate a positive difference in the overall per patient treatment response rate (60% in the HyBryte group vs. 20% in the Valchlor group) at the end of treatment. After the 4-week follow-up period (Week 16), the majority (3 of 5) of HyBryte patients continued to demonstrate improvement with at least a further 10% improvement (absolute difference) at Week 16 relative to the primary outcome measure at Week 12, including one of the HyBryte patients achieving a "complete response". In contrast, of the four patients that completed the Valchlor arm of the study, none achieved this level of improvement by Week 16. For patients, a treatment response was defined as a ≥50% improvement in their cumulative mCAILS (modified Composite Assessment of Index Lesion Severity) score over 3 to 5 lesions. Treatment response was also assessed on individual lesions. There was a similar continued improvement in the lesion responses over time, with the plaque lesions of particular interest given their increasing association with risk of overall disease progression and long-term mortality. At the 12-week (end of treatment) timepoint, the HyBryte treated plaque lesions were statistically significantly improved compared to the Valchlor treated plaques (63%, [10/16] treatment success with HyBryte vs. 17%, [2/12] with Valchlor, p=0.02). By Week 16, the response rates in lesions treated with HyBryte were statistically significant responses for all lesions (72% HyBryte vs 28% Valchlor, p=0.02) and specifically for plaque lesions (75% responding plaque lesions with HyBryte treatment vs. 17% with Valchlor, p=0.006) relative to the Valchlor group. No safety concerns with HyBryte were raised during the follow-up period.

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"Following the positive results from the previous Phase 2 and 3 studies where we previously participated in evaluating HyBryte, we were excited to support Soligenix’s effort to conduct a prospective comparative assessment of HyBryte versus Valchlor," stated Dr. Brian Poligone, Director of the Rochester Skin Lymphoma Medical Group, and Principal Investigator for the comparability study. "Despite the small study sample size and a randomization that resulted in the HyBryte group having patients with more extensive disease, HyBryte continues to demonstrate its rapid onset of action and benign safety profile, compared to one of the most widely prescribed approved drugs for early-stage CTCL. The potentially enhanced effect on plaque lesions mirrors the promising activity against very difficult to treat lesions, such as refractory folliculotropic lesions, which we also observed in the first Phase 3 study. We look forward to continuing our support of Soligenix in the development of HyBryte by participating in the upcoming confirmatory Phase 3 placebo-controlled study."

"These results support the positive HyBryte data from the previously completed Phase 3 FLASH study and demonstrates that a relatively short treatment period with the drug can result in clinically meaningful outcomes," stated Christopher J. Schaber, PhD, President and Chief Executive Officer of Soligenix. "This relatively rapid response to HyBryte therapy fits nicely into the treatment arsenal for CTCL and reinforces the relative safety of HyBryte in these patients compared to other therapies currently in use. We look forward to continuing to work with Dr. Poligone and all of our committed clinical investigators to initiate the 80-patient confirmatory Phase 3 replication study (FLASH2) next month."

The purpose of the HPN-CTCL-04 study was to obtain preliminary comparative assessment of the safety and efficacy of Valchlor versus HyBryte following 12 weeks of treatment as measured in 3 to 5 prospectively identified index lesions for each patient. HyBryte was administered twice weekly with light exposure approximately 24 hours after drug application, while Valchlor was applied as often as daily as per the package insert. At the end of the 12-week treatment period, 60% of the HyBryte patients met the prospectively defined level of "Treatment Success" (≥50% improvement in their cumulative mCAILS score compared to Baseline) compared to only 20% of the Valchlor patients; although due to the small sample size the results do not achieve statistical significance. Of the remaining two HyBryte patients that did not achieve treatment success, both saw a substantial (≥30%) reduction in their mCAILS score. In contrast, in the Valchlor group, of the remaining 4 patients that did not achieve treatment success, one worsened and dropped from the study, one improved less than 30% and two improved ≥30%. The average cumulative improvement in mCAILS at 12 weeks was 52.5% in the HyBryte patients versus 34.7% in the Valchlor patients. HyBryte was well tolerated in all patients whereas 1 of the 5 patients receiving Valchlor had to be withdrawn from the trial because of a clinically significant allergic contact dermatitis from Valchlor.

During the 4-week follow-up period (Week 16) the majority (3 of 5) of HyBryte patients continued to demonstrate lesion improvement with at least a further 10% reduction (absolute difference) at Week 16 relative to the primary outcome measure at Week 12, including one of these patients achieving a "complete response". The remaining two HyBryte subjects showed either a modest (<5%) decrease or increase relative to their primary endpoint response at Week 12. In contrast, of the four patients that completed the Valchlor arm of the study, one worsened (>15% change), one had a modest decrease, one remained static, and one had a modest improvement by Week 16. Analysis of the individual lesion responses showed similar response profiles, with treatment response observed in 61% of HyBryte treated lesions vs. 33% response in Valchlor treated lesions (p=0.18) at Week 12. The lesions responses increased over the 4 weeks following treatment to 72% responding lesions with HyBryte treatment and decreased over the 4 weeks following treatment to 28% with Valchlor, p=0.02. Focusing specifically on the plaque lesions, 63% of HyBryte treated plaque lesions (10/16) responded to treatment vs. 17% of Valchlor treated plaque lesions (2/12; p=0.02). Again, the responses of the HyBryte treated lesions increased over the 4 weeks following treatment to 75% responding plaque lesions with HyBryte treatment and the Valchlor treated lesions response rate was unchanged at 17%, p=0.006. Plaque lesions have been acknowledged as both more difficult to treat and, more recently, as potentially linked to disease progression. The link with disease progression was most recently reported at the European Organisation for Research and Treatment of Cancer (EORTC) Cutaneous Lymphoma Tumour Group Annual Meeting in Lausanne, Switzerland on October 9-11, 2024.

When comparing the tolerance of the topical therapies (i.e., reactions where the drug was applied to the skin) in this trial, it is notable that all patients tolerated HyBryte well and had no adverse events "Related" to the therapy. In contrast, 60% of the Valchlor treated patients had at least one adverse event "Related" to the therapy. These adverse events in the Valchlor group included rashes, application site sensitivity, allergic contact dermatitis, and dermatitis, with one patient requiring steroid treatment, one requiring temporary interruption of Valchlor treatments, and one requiring permanent discontinuation of Valchlor. No such instances were reported in the HyBryte group.

About HyBryte

HyBryte (research name SGX301) is a novel, first-in-class, photodynamic therapy utilizing safe, visible light for activation. The active ingredient in HyBryte is synthetic hypericin, a potent photosensitizer that is topically applied to skin lesions that is taken up by the malignant T-cells, and then activated by safe, visible light approximately 24 hours later. The use of visible light in the red-yellow spectrum has the advantage of penetrating more deeply into the skin (much more so than ultraviolet light) and therefore potentially treating deeper skin disease and thicker plaques and lesions. This treatment approach avoids the risk of secondary malignancies (including melanoma) inherent with the frequently employed DNA-damaging drugs and other phototherapy that are dependent on ultraviolet exposure. Combined with photoactivation, hypericin has demonstrated significant anti-proliferative effects on activated normal human lymphoid cells and inhibited growth of malignant T-cells isolated from CTCL patients. In a published Phase 2 clinical study in CTCL, patients experienced a statistically significant (p=0.04) improvement with topical hypericin treatment whereas the placebo was ineffective. HyBryte has received orphan drug and fast track designations from the U.S. Food and Drug Administration (FDA), as well as orphan designation from the European Medicines Agency (EMA).

The published Phase 3 FLASH trial enrolled a total of 169 patients (166 evaluable) with Stage IA, IB or IIA CTCL. The trial consisted of three treatment cycles. Treatments were administered twice weekly for the first 6 weeks and treatment response was determined at the end of the 8th week of each cycle. In the first double-blind treatment cycle (Cycle 1), 116 patients received HyBryte treatment (0.25% synthetic hypericin) and 50 received placebo treatment of their index lesions. A total of 16% of the patients receiving HyBryte achieved at least a 50% reduction in their lesions (graded using a standard measurement of dermatologic lesions, the CAILS score) compared to only 4% of patients in the placebo group at 8 weeks (p=0.04) during the first treatment cycle (primary endpoint). HyBryte treatment in this cycle was safe and well tolerated.

In the second open-label treatment cycle (Cycle 2), all patients received HyBryte treatment of their index lesions. Evaluation of 155 patients in this cycle (110 receiving 12 weeks of HyBryte treatment and 45 receiving 6 weeks of placebo treatment followed by 6 weeks of HyBryte treatment), demonstrated that the response rate among the 12-week treatment group was 40% (p<0.0001 vs the placebo treatment rate in Cycle 1). Comparison of the 12-week and 6-week treatment responses also revealed a statistically significant improvement (p<0.0001) between the two timepoints, indicating that continued treatment results in better outcomes. HyBryte continued to be safe and well tolerated. Additional analyses also indicated that HyBryte is equally effective in treating both plaque (response 42%, p<0.0001 relative to placebo treatment in Cycle 1) and patch (response 37%, p=0.0009 relative to placebo treatment in Cycle 1) lesions of CTCL, a particularly relevant finding given the historical difficulty in treating plaque lesions in particular.

The third (optional) treatment cycle (Cycle 3) was focused on safety and all patients could elect to receive HyBryte treatment of all their lesions. Of note, 66% of patients elected to continue with this optional compassionate use / safety cycle of the study. Of the subset of patients that received HyBryte throughout all 3 cycles of treatment, 49% of them demonstrated a positive treatment response (p<0.0001 vs patients receiving placebo in Cycle 1). Moreover, in a subset of patients evaluated in this cycle, it was demonstrated that HyBryte is not systemically available, consistent with the general safety of this topical product observed to date. At the end of Cycle 3, HyBryte continued to be well tolerated despite extended and increased use of the product to treat multiple lesions.

Overall safety of HyBryte is a critical attribute of this treatment and was monitored throughout the three treatment cycles (Cycles 1, 2 and 3) and the 6-month follow-up period. HyBryte’s mechanism of action is not associated with DNA damage, making it a safer alternative than currently available therapies, all of which are associated with significant, and sometimes fatal, side effects. Predominantly these include the risk of melanoma and other malignancies, as well as the risk of significant skin damage and premature skin aging. Currently available treatments are only approved in the context of previous treatment failure with other modalities and there is no approved front-line therapy available. Within this landscape, treatment of CTCL is strongly motivated by the safety risk of each product. HyBryte potentially represents the safest available efficacious treatment for CTCL. With very limited systemic absorption, a compound that is not mutagenic and a light source that is not carcinogenic, there is no evidence to date of any potential safety issues.

Following the first Phase 3 study of HyBryte for the treatment of CTCL, the FDA and the EMA indicated that they would require a second successful Phase 3 trial to support marketing approval. With agreement from the EMA on the key design components, the second, confirmatory study, called FLASH2, is expected to be initiated before the end of 2024. This study is a randomized, double-blind, placebo-controlled, multicenter study that will enroll approximately 80 subjects with early-stage CTCL. The FLASH2 study replicates the double-blind, placebo-controlled design used in the first successful Phase 3 FLASH study that consisted of three 6-week treatment cycles (18 weeks total), with the primary efficacy assessment occurring at the end of the initial 6-week double-blind, placebo-controlled treatment cycle (Cycle 1). However, this second study extends the double-blind, placebo-controlled assessment to 18 weeks of continuous treatment (no "between-Cycle" treatment breaks) with the primary endpoint assessment occurring at the end of the 18-week timepoint. In the first Phase 3 study, a treatment response of 49% (p<0.0001 vs patients receiving placebo in Cycle 1) was observed in patients completing 18 weeks (3 cycles) of therapy. In this second study, all important clinical study design components remain the same as in the first FLASH study, including the primary endpoint and key inclusion-exclusion criteria. The extended treatment for a continuous 18 weeks in a single cycle is expected to statistically demonstrate HyBryte’s increased effect over a more prolonged, "real world" treatment course. Given the extensive engagement with the CTCL community, the esteemed Medical Advisory Board and the previous trial experience with this disease, accelerated enrollment in support of this study is anticipated, including the potential to enroll previously identified and treated HyBryte patients from the FLASH study. Discussions with the FDA on an appropriate study design remain ongoing. While collaborative, the agency has expressed a preference for a longer duration comparative study over a placebo-controlled trial. Given the shorter time to potential commercial revenue and the similar trial design to the first FLASH study afforded by the EMA accepted protocol, this study is being initiated. At the same time, discussions with the FDA will continue on potential modifications to the development path to adequately address their feedback.

In addition, the FDA awarded an Orphan Products Development grant to support the evaluation of HyBryte for expanded treatment in patients with early-stage CTCL, including in the home use setting. The grant, totaling $2.6 million over 4 years, was awarded to the University of Pennsylvania that was a leading enroller in the Phase 3 FLASH study.

About Cutaneous T-Cell Lymphoma (CTCL)

CTCL is a class of non-Hodgkin’s lymphoma (NHL), a type of cancer of the white blood cells that are an integral part of the immune system. Unlike most NHLs which generally involve B-cell lymphocytes (involved in producing antibodies), CTCL is caused by an expansion of malignant T-cell lymphocytes (involved in cell-mediated immunity) normally programmed to migrate to the skin. These malignant cells migrate to the skin where they form various lesions, typically beginning as patches and may progress to raised plaques and tumors. Mortality is related to the stage of CTCL, with median survival generally ranging from about 12 years in the early stages to only 2.5 years when the disease has advanced. There is currently no cure for CTCL. Typically, CTCL lesions are treated and regress but usually return either in the same part of the body or in new areas.

CTCL constitutes a rare group of NHLs, occurring in about 4% of the more than 1.7 million individuals living with the disease in the U.S. and Europe (European Union and United Kingdom). It is estimated, based upon review of historic published studies and reports and an interpolation of data on the incidence of CTCL that it affects approximately 31,000 individuals in the U.S. (based on SEER data, with approximately 3,200 new cases seen annually) and approximately 38,000 individuals in Europe (based on ECIS prevalence estimates, with approximately 3,800 new cases annually).

On December 2, 2024 Alligator Bioscience AB ("Alligator Bioscience" or the "Company") reported, subject to approval by an extraordinary general meeting on 13 January 2025, resolved to carry out an issue of ordinary shares and warrants ("units") with preferential rights for the Company’s existing shareholders of initially approximately SEK 280 million (the "Rights Issue") (Press release, Alligator Bioscience, DEC 2, 2024, View Source [SID1234648711]). The Company has received subscription undertakings amounting to a total of approximately SEK 16 million, corresponding to approximately 6 percent of the Rights Issue. Furthermore, the Company has received guarantee commitments amounting to a total of approximately SEK 124 million, corresponding to approximately 44 percent of the Rights Issue, which in total is covered by subscription undertakings and guarantee commitments of approximately SEK 140 million, corresponding up to approximately 50 percent of the Rights Issue. A number of existing shareholders, that combined represent approximately 33.4 percent of the total number of votes in the Company, have declared their support for the Rights Issue and have entered into voting undertakings or declared their intention to vote in favor of the Right Issue at the extraordinary general meeting. Alligator Bioscience intends to use the proceeds from the Rights Issue, after repayment of bridge loans and part of the loans that Alligator Bioscience raised from Fenja Capital II A/S ("Fenja Capital") earlier in 2024, to support the development of mitazalimab towards Phase 3 and securing a partnership for mitazalimab as well as for general corporate purposes. The Rights Issue is subject to approval by an extraordinary general meeting on 13 January 2025. The notice of the extraordinary general meeting will be announced in a separate press release. To secure the Company’s liquidity needs until the completion of the Rights Issue, the Company has entered into agreements on bridge loans of a total of SEK 55 million on market terms. In connection with the Rights Issue, Alligator Bioscience has also renegotiated the outstanding loans and convertibles raised in June 2024 from Fenja Capital. As part of the renegotiation, Alligator Bioscience has undertaken to issue additional warrants series TO 10 and TO 11 free of charge to Fenja Capital under certain conditions.

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Summary

The Rights Issue includes units and will initially, if fully subscribed, provide Alligator Bioscience with approximately SEK 280 million before issue costs. Each unit consists of ten (10) ordinary shares, ten (10) warrants series TO 10 and five (5) warrants series TO 11. The warrants series TO 10 and TO 11 are intended to be admitted to trading on Nasdaq Stockholm.
One (1) warrant series TO 10 entitles the holder to subscription of one (1) ordinary share in the Company during the period from and including 5 May 2025 up to and including 19 May 2025. Thus, the Company may receive additional proceeds in May 2025 if the warrants series TO 10, including the warrants series TO 10 that may be issued separately to Fenja Capital as detailed below, are exercised for subscription of new ordinary shares.
The exercise price for the warrants series TO 10 shall correspond to seventy (70) percent of the volume-weighted average price of the Company’s ordinary share on Nasdaq Stockholm during the period from and including 11 April 2025 up to and including 28 April 2025, however not lower than the higher of (i) the quota value of the share or (ii) SEK 0.01, and not higher than 125 percent of the subscription price per ordinary share in the Rights Issue.
One (1) warrant series TO 11 entitles the holder to subscription of one (1) ordinary share in the Company during the period from and including 1 September 2025 up to and including 15 September 2025. Thus, the Company may receive additional proceeds in September 2025 if the warrants series TO 11, including the warrants series TO 11 that may be issued separately to Fenja Capital as detailed below, are exercised for subscription of new ordinary shares.
The exercise price for the warrants series TO 11 shall correspond to seventy (70) percent of the volume-weighted average price of the Company’s ordinary share on Nasdaq Stockholm during the period from and including 14 August 2025 up to and including 27 August 2025, however not lower than the higher of (i) the quota value of the share or (ii) SEK 0.01, and not higher than 125 percent of the subscription price per ordinary share in the Rights Issue.
Final terms of the Rights Issue, including subscription price, increase of the share capital and number of ordinary shares and warrants issued, are intended to be published no later than 17 January 2025. The subscription price for each unit is intended to be set based on a discount to TERP (theoretical share price after separation of unit rights) of approximately 40 percent based on the volume-weighted average share price of the Company’s ordinary share on Nasdaq Stockholm during the period from and including 3 January 2025 up to and including 17 January 2025, however not less than SEK 0.01, multiplied by ten (10) (the "Subscription Price").
A number of existing shareholders, that combined represent approximately 33.4 percent of the total number of votes in the Company, have declared their support for the Rights Issue and have entered into voting undertakings or declared their intention to vote in favor of the Rights Issue at the extraordinary general meeting scheduled to be held on 13 January 2025.
The Rights Issue is covered to approximately 6 percent by subscription undertakings and to approximately 44 percent by guarantee commitments, corresponding to a total of approximately 50 percent of the Rights Issue in total.
Provided that the Rights Issue is approved by the extraordinary general meeting on 13 January 2025, the record date for the Rights Issue will be 27 January 2025, and the subscription period will run from and including 29 January 2025 up to and including 12 February 2025.
The last day of trading in the Company’s shares including right to receive unit rights in the Rights Issue is 23 January 2025 and the first day of trading in the Company’s shares without the right to receive unit rights in the Rights Issue is 24 January 2025.
Trading in unit rights will take place on Nasdaq Stockholm from and including 29 January 2025 up to and including 7 February 2025.
To secure the Company’s liquidity needs until the completion of the Rights Issue, the Company has entered into agreements on bridge loans of a total of SEK 55 million on market terms.
In connection with the Rights Issue, Alligator Bioscience has renegotiated the outstanding loans and convertibles raised in June 2024 from Fenja Capital.
The Company intends to publish a prospectus regarding the Rights Issue around 24 January 2025 (the "Prospectus").
Søren Bregenholt, CEO of Alligator Bioscience, comments:
"Following the exceptional 18-month Phase 2 data reported for lead candidate mitazalimab in 1st line metastatic pancreatic cancer, we now increase our focus on advancing this asset towards Phase 3 development and partnering and on our objective to deliver outstanding returns to our shareholders. The Company estimates that with the previously announced restructuring of our organization, the rights issue, including the warrants included herein, should secure our finances for the coming 12 months at the secured level of the rights issue. I am pleased to have investors’ confidence in this updated strategy, which will see us deliver on several value inflection points on mitazalimab the coming year, notably the 24-months survival data from the ongoing Phase 2 study, as well as key updates from our ongoing regulatory dialogues. Together, we share the determination of bringing mitazalimab to the market, and to the patients and their friends and families who suffer from this devastating disease."
Background and reason for the Rights Issue
Alligator Bioscience is a research-based biotechnology company developing antibody-based pharmaceuticals for cancer treatment. The Company specializes in the development of tumor-directed immunotherapies, in particular agonistic mono- and bispecific antibodies. In immunotherapy, the patients’ immune system is activated to cure cancer. The term tumor-directed means that the drug is administered or designed such that the pharmacological effect is localized to the tumor. This results in an advantageous efficacy and safety profile.

The clinical drug candidate mitazalimab (previously ADC-1013) is an agonistic, or stimulatory, antibody that targets CD40, a receptor on the dendritic cells of the immune system, which are the cells that detect enemies such as cancer cells. In preclinical experimental models, mitazalimab has been shown to induce a potent tumor-targeted immune response and provide long-lasting tumor immunity. In addition, preclinical data have demonstrated how mitazalimab can be used against multiple types of cancer. The study OPTIMIZE-1 is an open-label, multi-center trial assessing the clinical efficacy of mitazalimab in combination with chemotherapy (mFOLFIRINOX) in patients with first line metastatic pancreatic cancer. The trial was initiated in Q3 2021, and top line data was announced on 29 January 2024 showing that the trial met the primary endpoint. On 26 June 2024, the Company announced 18-month data, demonstrating an Objective Response Rate of 42.4 percent, a Median Overall Survival of 14.9 months and a survival rate at 18 months of 36.2 percent, nearly twice as high as the 18.6 percent previously reported for FOLFIRINOX. Together these data confirm the benefit of mitazalimab in combination with mFOLFIRINOX. On 24 October 2024, the Company announced that 16 patients were still in the study and that at least 6 patients had been in the study for more than two years, thus further strengthening the case for mitazalimab. The Company expects to announce 24-month follow-up data during Q1 2025 together with the conclusion from a number of planned interactions with the US FDA.

Alligator Bioscience has today separately announced a sharpened focus on mitazalimab and the implementation of a cost reduction program to maximize long-term value creation, which is assessed to potentially enable a reduction of approximately 70 percent of the current workforce, mainly affecting the discovery and non-clinical operations. Once implemented, the restructuring is expected to reduce operational costs by at least SEK 65 million annually. Going forward, Alligator Bioscience will focus on late-stage development with an adequate workforce of approximately 15 FTEs. Furthermore, Alligator Bioscience will continue to be able to conduct limited research activities, primarily related to mitazalimab, through internal and external resources.

Given the capital needs that the Company’s development and commercialization plans give rise to, Alligator Bioscience assesses that its existing working capital, together with the potential capital raise from the warrants series TO 9, exercisable in December 2024, is not sufficient to cover the Company’s capital needs for the upcoming twelve months. To ensure continued successful progress in accordance with the Company’s revised business plan and strategy, Alligator Bioscience has therefore decided to carry out the Rights Issue.

Upon full subscription in the Rights Issue, the Company will initially receive approximately SEK 280 million before issue costs. The costs related to the Rights Issue are estimated at full subscription, to amount to a maximum of approximately SEK 33 million, of which approximately SEK 15 million is attributable to guarantee compensation (provided that all guarantors choose to receive the compensation in cash). The expected net proceeds from the Rights Issue are thus estimated to amount to approximately SEK 247 million. The net proceeds from the Rights Issue, after repayment of bridge loans and part of the loans that Alligator Bioscience raised from Fenja Capital earlier in 2024 as detailed below, are intended to support the development of mitazalimab towards Phase 3 and securing a partnership for mitazalimab as well as for general corporate purposes.

In May 2025, the Company may receive additional proceeds if the warrants series TO 10 issued in the Rights Issue are exercised for subscription of ordinary shares. The net proceeds from the exercise of warrants series TO 10, including the warrants series TO 10 that may be issued separately to Fenja Capital as detailed below, are intended to be used, with 50 percent of the part exceeding SEK 10 million, to repay outstanding loans from Fenja Capital and the remaining part, including the net proceeds up to SEK 10 million, as working capital for the Company.

In September 2025, the Company may receive additional proceeds if the warrants series TO 11 issued in the Rights Issue are exercised for subscription of ordinary shares. The net proceeds from the exercise of warrants series TO 11, including the warrants series TO 11 that may be issued separately to Fenja Capital as detailed below, are intended to be used by 50 percent as working capital for the Company and by 50 percent to repay any outstanding part of loans from Fenja Capital.

Terms of the Rights Issue
The Board of Directors has today, subject to the approval by the extraordinary general meeting on 13 January 2025, resolved on an issue of units consisting of ordinary shares, warrants series TO 10 and warrants series TO 11, with preferential rights for existing shareholders. Through the Rights Issue, Alligator Bioscience may receive initial issue proceeds of approximately SEK 280 million, excluding the additional proceeds that may be received upon exercise of the warrants series TO 10 and TO 11 that are issued in the Rights Issue. Those who are registered as shareholders in the Company on the record date 27 January 2025 are entitled to subscribe for units with preferential rights.

Final terms of the Rights Issue, including Subscription Price, increase of the share capital and number of ordinary shares and warrants issued, are intended to be published no later than 17 January 2025. Each unit consists of ten (10) ordinary shares, ten (10) warrants series TO 10 and five (5) warrants series TO 11. The warrants series TO 10 and TO 11 are issued free of charge. The Subscription Price is intended to be set based on a discount to TERP (theoretical share price after separation of unit rights) of approximately 40 percent based on the volume-weighted average share price of the Company’s ordinary share on Nasdaq Stockholm during the period from and including 3 January 2025 up to and including 17 January 2025, however not less than SEK 0.01, multiplied by ten (10). The warrants series TO 10 and TO 11 are intended to be admitted to trading on Nasdaq Stockholm.

Subscription of units with or without preferential rights shall be made during the period from and including 29 January 2025 up to and including 12 February 2025. Unit rights that are not exercised during the subscription period will become invalid and lose their value. Trading in unit rights takes place on Nasdaq Stockholm during the period from and including 29 January 2025 up to and including 7 February 2025 and trading in BTU (paid subscribed units, "BTU") during the period from and including 29 January 2025 up to and including 28 February 2025.

One (1) warrant series TO 10 entitles the holder the right to subscribe for one (1) new ordinary share in the Company at a subscription price corresponding to seventy (70) percent of the volume-weighted average price of the Company’s ordinary share on Nasdaq Stockholm during the period from and including 11 April 2025 up to and including 28 April 2025, however not lower than the higher of (i) the quota value of the share or (ii) SEK 0.01, and not higher than 125 percent of the Subscription Price per ordinary share in the Rights Issue. Subscription of shares by exercise of warrants series TO 10 shall be made during the period from and including 5 May 2025 up to and including 19 May 2025.

One (1) warrant series TO 11 entitles the holder the right to subscribe for one (1) new ordinary share in the Company at a subscription price corresponding to seventy (70) percent of the volume-weighted average price of the Company’s ordinary share on Nasdaq Stockholm during the period from and including 14 August 2025 up to and including 27 August 2025, however not lower than the higher of (i) the quota value of the share or (ii) SEK 0.01, and not higher than 125 percent of the Subscription Price per ordinary share in the Rights Issue. Subscription of shares by exercise of warrants series TO 11 shall be made during the period from and including 1 September 2025 up to and including 15 September 2025.

If not all units are subscribed for by exercise of unit rights, allotment of the remaining units shall be made within the highest amount of the issue: firstly, to those who have subscribed for units by exercise of unit rights (regardless of whether they were shareholders on the record date or not) and who have applied for subscription of units without exercise of unit rights and if allotment to these cannot be made in full, allotment shall be made pro rata in relation to the number of unit rights that each and every one of those, who have applied for subscription of units without exercise of unit rights, have exercised for subscription of units; secondly, to those who have applied for subscription of units without exercise of unit rights and if allotment to these cannot be made in full, allotment shall be made pro rata in relation to the number of units the subscriber in total has applied for subscription of units; and thirdly, to those who have provided guarantee commitments with regard to subscription of units, in proportion to such guarantee commitments. To the extent that allotment in any section above cannot be done pro rata, allotment shall be determined by drawing of lots.

Subscription undertakings and guarantee commitments
The Company has received subscription undertakings from a number of existing shareholders, including Roxette Photo SA as well as the Company’s chairman of the Board, Anders Ekblom, and CEO, Søren Bregenholt, amounting in total to approximately SEK 16 million, corresponding to approximately 6 percent of the Rights Issue. No compensation will be paid for subscription undertakings.

The Company has also entered into agreements with a number of external investors on guarantee commitments of a total of approximately SEK 124 million, corresponding to approximately 44 percent of the Rights Issue. The guarantee commitments are composed partly of a so called top guarantee of SEK 20 million and partly of so called bottom guarantees of approximately SEK 104 million in total. According to the guarantee agreements, for the top guarantee as well as for the bottom guarantees, cash compensation is paid with 12 percent of the guaranteed amount, corresponding to a total of approximately SEK 15 million, or 14 percent of the guaranteed amount in the form of newly issued units in the Company, with the same terms and conditions as for units in the Rights Issue, including the Subscription Price in the Rights Issue.

In total, the Rights Issue is covered by subscription undertakings and guarantee commitments amounting up to approximately SEK 140 million, corresponding to approximately 50 percent of the Rights Issue.

In order to enable issue of units as guarantee compensation to the guarantors who choose to receive guarantee compensation in the form of newly issued units, the Board of Directors has proposed that the extraordinary general meeting on 13 January 2025, among other things, resolves on approval of the Rights Issue and authorization for the Board of Directors to resolve on issue of such units to guarantors.

A subscription of units in the Rights Issue (other than by exercising preferential rights) which result in an investor acquiring a shareholding corresponding to or exceeding a threshold of ten (10) percent or more of the total number of votes in the Company following the completion of the Rights Issue, must prior to the investment be filed with the Inspectorate of Strategic Products (Sw. Inspektionen för strategiska produkter). To the extent any guarantors’ fulfilment of their guarantee commitment entails that the investment must be approved by the Inspectorate of Strategic Products in accordance with the Swedish Screening of Foreign Direct Investments Act (Sw. lagen (2023:560) om granskning av utländska direktinvesteringar), such part of the guarantee is conditional upon notification that the application of the transaction is left without action or that approval has been obtained from the Inspectorate of Strategic Products.

Preliminary time plan for the Rights Issue

13 January 2025 Extraordinary general meeting
17 January 2025 Publication of final terms of the Rights Issue, including Subscription Price
23 January 2025 Last day of trading incl. preferential rights
24 January 2025 Estimated publication of the Prospectus
24 January 2025 First day of trading excl. preferential rights
27 January 2025 Record date in the Rights Issue
29 January 2025 – 7 February 2025 Trading in unit rights
29 January 2025 – 12 February 2025 Subscription period
14 February 2025 Estimated publication of the outcome of the Rights Issue
29 January 2025 – 4 March 2025 Trading in paid subscribed units (BTU)
Lock-up agreements
In connection with the Rights Issue, all shareholding members of the Board of Directors and senior management in Alligator Bioscience have undertaken towards Vator Securities AB, subject to customary exceptions, not to sell or carry out other transactions with a similar effect as a sale unless, in each individual case, first having obtained written approval from Vator Securities AB. Decisions to give such written consent are resolved upon by Vator Securities AB and an assessment is made in each individual case. Consent may depend on both individual and business reasons. The lock-up undertakings only cover the shares held prior to the Rights Issue and the lock-up period lasts for 180 days after the announcement of the Rights Issue.

Extraordinary general meeting and support from major shareholders
The Board of Directors’ resolution on the Rights Issue is subject to approval by the extraordinary general meeting on 13 January 2025. The resolution on the Rights Issue is subject to and conditional upon that the extraordinary general meeting also resolves to amend the Articles of Association in accordance with the Board of Directors’ proposal to the extraordinary general meeting, as well as authorizations for the Board of Directors to resolve on issue of units to the guarantors and warrants to Fenja Capital. Notice of the extraordinary general meeting will be announced in a separate press release.

A number of existing shareholders, that combined represent approximately 33.4 percent of the total number of votes in the Company have declared their support for the Rights Issue and have entered into voting undertakings or declared their intention to vote in favor of the Rights Issue at the extraordinary general meeting. The Board of Directors therefore believes that the conditions for successfully completing the Rights Issue are favorable.

Bridge loans and renegotiation of previous loans and convertibles
In order to secure the Company’s liquidity needs until the Rights Issue has been completed, the Company has raised bridge loans of a total of SEK 55 million from a consortium of external investors. As compensation for the loans an arrangement fee of 5 percent and a monthly interest rate of 1.25 percent are paid. According to the bridge loans, the loans shall be repaid in connection with the Rights Issue or no later than 25 March 2025.

In June 2024, Alligator Bioscience entered into a financing agreement with Fenja Capital pursuant to which Fenja Capital has provided loans with an aggregate nominal amount of SEK 68 million and furthermore also subscribed for convertibles with an aggregate nominal amount of SEK 12 million. For further details, please see the Company’s press release from 25 June 2024. In connection with the Rights Issue, Alligator Bioscience has renegotiated the outstanding financing from Fenja Capital. Alligator Bioscience will, in connection with the Rights Issue, repay the entire outstanding nominal amount under the convertibles of SEK 12 million and at least SEK 23 million of the outstanding nominal amount under the loans by set-off or payment in cash (depending on allotment in the Rights Issue). Furthermore, to the extent the initial gross proceeds received by the Company in the Current Issue exceeds SEK 140 million, the Company shall utilize an amount corresponding to 47 percent of the proceeds in excess of SEK 140 million towards additional repayment of the previous loans. After the repayments, not more than SEK 45 million will be outstanding (the "New Loan").

The New Loan is subject to an arrangement fee of 5 percent of the loan amount and the loan bears an annual interest rate at STIBOR 3M (however minimum 3 percent) plus an interest margin of 10 percent, paid on a quarterly basis. In connection with repayment of the New Loan a repayment fee is also payable amounting to 3 percent of the repaid nominal amount. This repayment fee is also payable in connection with the potential additional repayment to be made in connection with the Rights Issue if the gross proceeds exceed SEK 140 million.

The maturity date for the New Loan is 30 November 2025.

In addition to the mandatory early repayment dates included in the original financing agreement, the Company shall, upon exercise of the warrants series TO 10, use 50 percent of the part of the net proceeds that exceeds SEK 10 million for repayment of the New Loan, and the Company shall, upon exercise of the warrants series TO 11, use 50 percent of the total net proceeds for repayment of the New Loan. Furthermore, to the extent that the outstanding New Loan at the end of a calendar quarter, for the first time at the end of the second quarter of 2025, exceeds 10 percent of the Company’s market capitalization, the Company shall repay an amount of SEK 5 million.

In connection with the New Loan, Alligator Bioscience has undertaken to issue warrants series TO 10 and TO 11 to Fenja Capital, free of charge. The warrants will be of the same series issued in the Rights Issue and thus have the same terms and conditions in relation to subscription price, exercise period etc. The number of warrants series TO 10 and TO 11 to be issued will be based on the nominal amount of the New Loan (up to SEK 45 million), as if such nominal amount was used for subscription in the Rights Issue, i.e. calculated as New Loan (not more than SEK 45 million) divided by the Subscription Price per unit and then multiplying with the number of warrants series TO 10 and TO 11, respectively, included in each unit, rounded downwards to the nearest whole number. The Board of Directors intends to resolve on the issue of warrants series TO 10 and TO 11 to Fenja Capital pursuant to an authorization from the extraordinary general meeting intended to be held on 13 January 2025, no later than five business days following the registration of the Rights Issue with the Swedish Companies Registration Office.
Prospectus
Full terms and conditions for the Rights Issue, as well as other information about the Company and information about subscription undertakings, guarantee commitments and lock-up agreements will be presented in the Prospectus that the Company is expected to publish on or around 24 January 2025.

Warrants series TO 9
The Rights Issue does not impact the outstanding warrants series TO 9 where the exercise period will commence on 4 December 2024 and run up to and including 18 December 2024. The exercise price for the warrants series TO 9 will be announced in a separate press release.

Advisers
Vator Securities AB acts as Sole Global Coordinator and bookrunner in connection with the Rights Issue and Van Lanschot Kempen N.V. acts as financial adviser to Alligator Bioscience in connection with the Rights Issue. Setterwalls Advokatbyrå AB is legal adviser to Alligator Bioscience in connection with the Rights Issue. Vator Securities AB acts as the issuing agent in connection with the Rights Issue.

On December 2, 2024 Theratechnologies Inc. ("Theratechnologies" or the "Company") (TSX: TH) (NASDAQ: THTX), a biopharmaceutical company focused on the development and commercialization of innovative therapies, reported that it has closed on a $40 million three-year non-dilutive, senior secured syndicated financing with TD Bank, as agent (TD Bank Financing) (Press release, Theratechnologies, DEC 2, 2024, View Source [SID1234648728]). The new credit facilities include a $20 million accordion feature, which could expand total commitments up to $60 million. Investissement Québec (IQ), the Company’s largest shareholder, has also agreed to provide a $15 million second ranking secured subordinated term loan (IQ Subordinated Loan). Net proceeds from the new loans together with cash on hand will be used to repay all obligations including prepayment penalties under the Company’s existing facility with affiliates of Marathon Asset Management, L.P. (Marathon) pursuant to the credit agreement entered into with Marathon in July 2022, and to fund business development activities. All amounts are in US dollars unless otherwise stated.

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"This transaction represents a critical milestone for the Company’s strategic focus on the commercialization of innovative therapies through business development deals and partnerships," said Philippe Dubuc, Senior Vice President and Chief Financial Officer at Theratechnologies. "The new facility’s favorable rates and terms provide us with meaningful financial flexibility to execute on our acquisition strategy at substantially lower costs. The flexible structure fully aligns with our strategic objectives of continuing to enhance profitability and strengthen our balance sheet to fuel long-term growth and sustainability."

Key highlights of the TD Bank Financing include:

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$25 million senior secured term loan and a $15 million senior secured revolving facility; each with interest on a floating rate (SOFR) plus a margin based on the Company’s total net debt-to-Adjusted EBITDA ratio.

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At closing, the interest rate will be SOFR plus 2.75%. This rate compares favorably to the Company’s previous credit facility, which carried an interest rate of SOFR + 9.50%.

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The TD Bank term loan will be amortized over a seven-year period, and will mature on November 27, 2027.

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The Company has drawn $5 million on the revolving facility.

Key highlights of the IQ Subordinated Loan include:

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A $15 million second ranking secured subordinated term loan with interest based on US Government rates plus a margin based on the Company’s total net debt-to-Adjusted EBITDA ratio.

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The interest rate is currently set at US Government rates plus 7.23%, or 11.45%.

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The loan will be interest-only and be subject to full repayment after 42 months.

After giving effect to the financing, the Company will have $45 million in debt, with an estimated cash balance as at November 30, 2024 of approximately $20 million, for a net debt position of approximately $25 million.