On December 1, 2022 Philogen S.p.A. (BIT:PHIL), a clinical-stage biotech company focused on the development of
innovative medicines based on tumor targeting antibody and small molecule ligands, is pleased to provide an update on its R&D programs (Press release, Philogen, DEC 1, 2022, View Source [SID1234624689]).

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Dario Neri, co-founder, CEO and CSO of Philogen, commented: "We are very pleased with the recent progress of our pipeline. We currently have seven pivotal clinical trials underway with Nildegy and Fibromun for which we expect important readouts in the coming years. Our most advanced study is the one of Nidlegy in stage IIIB,C melanoma and we expect to reach 95 events to complete the trial in 2023.

Based on the complete remissions being observed with Nidlegy in high-risk Basal Cell Carcinoma (BCC), the Company is committed to expand the number of clinical centers to speed up timelines. It is important to highlight that the market potential in high-risk BCC is potentially larger than the melanoma market. We have the ambition to turn Nidlegy into a broad applicable dermato-oncology drug.

Fibromun’s registration studies remain on track, both in Soft Tissue Sarcoma and in Glioblastoma.

Our Discovery Center has been very productive, having published more than 15 scientific peer reviewed publications and has initiated
two novel collaborations with Bracco imaging and Janssen which are currently ongoing.
Our Group is increasing its investments in the discovery of small molecule tumor-targeting agents, which may facilitate the selective
delivery of therapeutic radionuclides (Small Molecule Radiolabeled Conjugates, or "SMRCs") and of non-radioactive drugs (Small
Molecule Drug Conjugates, or "SMDCs"). The excellent targeting properties of our OncoFAP small molecule ligand bode well for
delivering both therapeutic radionuclides and cytotoxic drugs to tumors. Stimulated by curative activity observed in "difficult-to-treat"
preclinical models of cancer, preparation activities for therapeutic trials with the OncoFAP platform are ongoing."
MAIN EVENTS AND RECENT HIGHLIGHTS
• Nidlegy – consists of two active ingredients, L19IL2 and L19TNF which are given intratumorally. The L19 antibody is specific
to the Extra Domain B of Fibronectin, a protein expressed in tumors (and other diseases) but absent in most healthy tissues.
Interleukin 2 (IL2) and Tumor Necrosis Factor (TNF) are inflammatory cytokines with anti-tumor activities
o Phase III European study in neoadjuvant (i.e., prior surgery) Stage IIIB,C melanoma (Pivotal)
▪ 214 patients have been enrolled, in line with the protocol of the study
▪ The trial will read-out when 95 events are reached. One event occurs when a patient’s tumor relapses
or when the patient passes away. As of December 1st, 80 out of 95 events have been recorded
▪ The study is ongoing in Germany, Italy, Poland, and France at 22 clinical centers
▪ The study has successfully passed two interim analyses in March 2019 (at 25% of total events) and
December 2020 (at 50% of total events). An independent Data and Safety Monitoring Board supported
the continuation of the trial based on Safety and Futility analyses
o Phase III USA study in neoadjuvant Stage IIIB,C melanoma (Neodream)
▪ The study is ongoing in the United States, Switzerland, and Spain at 23 clinical centers. More than 30
centers are expected to be open by 1H 2023.
▪ A larger number of centers are being activated, compared to the European trial described above to
speed up recruitment rate
o Phase II study in high-risk Basal Cell Carcinoma and cutaneous Squamous Cell Carcinoma (cSCC) (Duncan)
▪ Nine out of 40 patients have been enrolled. Eight patients were suffering from high-risk BCC and one
had cSCC

▪ The study is ongoing in Switzerland, Germany, and Poland. Seven clinical centers are currently open
and at least an additional site is expected to be activated by 1H 2023. Evidence of potent therapeutic
activity has emerged from the study and results have been presented at congresses in the field.
o Phase II study in a basket of Non-Melanoma Skin Cancers (NMSC) (Intrinsic)
▪ The trial has just started and foresees the treatment of 70 patients
▪ NMSC included in the trial are Kaposi’s sarcoma, cutaneous T-cell lymphoma, malignant adnexal tumors
of the skin, Keratocanthoma, Merkel Cell Carcinoma, cutaneous Squamous Cell Carcinoma, and Basal
Cell Carcinoma
▪ The study is ongoing in Italy and France. Three centers are currently open and at least two additional
sites are expected to be activated by 1H 2023
• Fibromun – a fully-human immunomodulatory product consisting of the L19 antibody and TNF (a strong pro-inflammatory
cytokine). Fibromun is administered by systemic intravenous infusion
o Phase III European study in newly diagnosed advanced or metastatic Soft Tissue Sarcoma (Fibrosarc)
▪ Fibromun is given in combination with Doxorubicin
▪ 47 out of 118 patients have been enrolled
▪ The study is ongoing in Germany, Italy, Spain, Poland, and soon also in France. 17 centers are currently
open and more than 25 are expected to be activated by 1H 2023
▪ The opening of the centers and the recruitment of patients are on track. The projections support the
completion of patient enrolment by the end of 2023
o Phase IIb USA study in newly diagnosed metastatic Leiomyosarcoma (Fibrosarc US)
▪ Fibromun is given in combination with Doxorubicin
▪ Leiomyosarcoma is the most common Soft Tissue Sarcoma subtype
▪ 9 clinical centers are currently open
o Phase II EU study in advanced or metastatic Soft Tissue Sarcoma patients that failed at least 2 prior systemic
therapies (Flash)
▪ Fibromun is given in combination with Dacarbazine
▪ 20 out of 92 patients have been enrolled
▪ Seven centers are currently open and more than 15 are expected to be activated by 1H 2023
o Phase I/II study in progressive High-Grade Stage III-IV Glioma (Gliomoon)
▪ Fibromun is given as monotherapy
▪ 20 out of 20 patients have been enrolled. The last patient was recruited in December 2020
▪ The study has been conducted at three clinical centers in Switzerland
▪ Data clean-up is ongoing and full results will be presented in a peer-reviewed scientific publication
o Phase I/II study in progressive Glioblastoma (Gliostar)
▪ Fibromun is given in combination with Lomustine
▪ 14 patients have been enrolled in the Phase I part. Cohort 1 and 2 have been completed, while Cohort
3 is ongoing. Cohort 3 is the last one before proceeding to the Phase II randomized part
▪ Substantially improved survival benefit and major durable responses observed both in Cohort 1 and
Cohort 2. Objective responses are very uncommon with lomustine alone
▪ More mature data of Cohorts 2 and 3 will be available in 1H 2023
▪ The randomized Phase II part of the study foresees 158 patients and is expected to start in 1H 2023
▪ The Phase I trial is currently ongoing at the University Hospital Zürich. Philogen has alreadycontacted
several centers in Switzerland, Italy, France, Germany, and in the USA, with the aim to open 18-20 sites
for the Phase II randomized part of the study
o Phase I/II/IIb study in newly-diagnosed Glioblastoma (Gliosun)
▪ Fibromun is given in combination with radiotherapy and temozolomide
▪ 9 patients have been enrolled in the Phase I part. Cohort 1 and 2 have been completed, while Cohort 3
is ongoing. 5 Cohorts in total are planned for Phase I, before proceeding to the Phase II single-arm part
▪ The Phase II part with 32 patients is expected to start in 2023
▪ The randomized Phase IIb part, with registration potential, foresees 166-206 and is expected to start
when consolidated data of Phase II become available
• OncoFAP is a small molecule ligand with ultra-high affinity for Fibroblast Activation Protein (FAP). The product is suitable
for diagnostic and therapeutic applications of a variety of metastatic solid tumors, as FAP is overexpressed in more than
90% of epithelial cancers (e.g., malignant breast, colorectal, ovarian, lung, skin, prostate, and pancreatic cancers, as well as
in some soft tissue and bone sarcomas)
o OncoFAP – radio-conjugate for imaging applications
▪ Several patients suffering from different cancers have already been imaged in Germany with 68GaOncoFAP
▪ The Italian Medicines Agency AIFA approved the Clinical Trial Application to formally initiate a Phase I
clinical trial in Italy. The first patient of the study is expected in the upcoming weeks
Main Office: Loc. Bellaria, 35 – 53018 Sovicille (SI), Italy
e-mail: [email protected] – website: www.philogen.com

o OncoFAP-23 – radio-conjugate for therapy applications
▪ OncoFAP-23 is an innovative derivative which shows excellent tumor targeting properties in pre-clinical
studies. The product selectively localizes rapidly into neoplastic lesions, with a stable uptake in the
tumor for at least 96h. The long-tumor residence time of the novel OncoFAP derivative bodes well for
therapeutic applications
▪
177Lu-OncoFAP-23 exerts potent anti-cancer activity in pre-clinical studies, which are superior to other
FAP-targeting agents
▪ The GMP production and central labelling of OncoFAP-23 are ongoing at the dedicated Contract
Research Organization
▪
177Lu-OncoFAP-23 is expected to enter in clinical trials by the end of 2023
o OncoFAP-GlyPro-MMAE – small molecule drug conjugate
▪ The Chemistry Group at Philochem (discovery center of the Philogen Group) has identified and tested
novel OncoFAP-based drug conjugates showing excellent tumor targeting and therapeutic properties
in pre-clinical models.
▪ OncoFAP-GlyPro-MMAE shows superior performance compared to other derivatives featuring
commonly used linkers in Antibody-Drug Conjugates (e.g., Valine-Citrulline linker)
▪ Small Molecule Drug Conjugates are an attractive alternative to ADCs, based on their superior targeting
performance and much lower Cost of Goods
• Ongoing partnerships include those on Dodekin (undisclosed), Dekavil (Pfizer), small molecule for diagnostic applications
(Bracco), and discovery of novel small molecule therapeutics (Janssen)
• GMP Facility in Rosia
o The construction and the equipment of the novel GMP facility in Rosia with state-of-the-art equipment have been
completed within the foreseen timelines.
o Three Aseptic Process Simulations (APS) have recently been successfully accomplished. APS simulates the aseptic
process of the so-called "fill and finish" step of a GMP production campaign and represents a crucial step before
initiating the manufacturing of commercial batches
o Authorization from the Italian Medicines Agency, AIFA of the new GMP production facility in Rosia for the
production and marketing of drugs is expected in 2023
o It should be noted that this new facility will complement the existing GMP plant in Montarioso (Siena), which will
be dedicated to the production of investigational drugs
The Group remains engaged in the strengthening of its in-house R&D, as well as contractual activities related to discovery and/or manufacturing. It also runs Business Development activities with potential industrial partners in order to seek new scientificcollaborations on an opportunistic basis.

On December 1, 2022 Outlook Therapeutics, Inc. (Nasdaq: OTLK), a biopharmaceutical company working to develop and launch the first FDA-approved ophthalmic formulation of bevacizumab for use in retinal indications, reported that Russ Trenary, President and Chief Executive Officer of Outlook Therapeutics, will participate in a panel discussion titled, "Take A Look At What’s In Store For Wet AMD & Related Diabetic Eye Diseases," at the Cantor Fitzgerald Medical & Aesthetic Dermatology, Ophthalmology & Medtech Conference on Thursday, December 8, 2022 at 2:45 PM ET (Press release, Outlook Therapeutics, DEC 1, 2022, View Source [SID1234624687]).

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In addition to the panel presentation, management will be available to participate in in-person one-on-one meetings with qualified members of the investor community who are registered to attend the conference.

The panel discussion is open to those who are registered to attend the event. Please contact your Cantor representative for more information.

On December 1, 2022 Oncternal Therapeutics, Inc. (Nasdaq: ONCT), a clinical-stage biopharmaceutical company focused on the development of novel oncology therapies, reported that it has granted an inducement award to one new employee, James Robinson, who joined Oncternal as Head of Biometrics & Data Sciences (Press release, Oncternal Therapeutics, DEC 1, 2022, View Source [SID1234624683]).

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The award was made on December 1, 2022 under Oncternal’s 2021 Employment Inducement Incentive Award Plan, which provides for the granting of equity awards to new employees of Oncternal as an inducement to join the Company. The award consists of an option to purchase 77,400 shares of Oncternal common stock. The option has a 10-year term and an exercise price equal to the closing price of Oncternal’s common stock on the date of grant. The option vests over a four-year period, with 25% of the shares subject to the option vesting on the first anniversary of the employee’s start date, and the rest vesting in equal monthly installments over three years thereafter. The award was approved by Oncternal’s compensation committee, comprised entirely of independent directors, as required by Nasdaq Rule 5635(c)(4), and was granted as an inducement material to the employee entering into employment with Oncternal in accordance with Nasdaq Rule 5635(c)(4).

On December 1, 2022 Oncolytics Biotech Inc. (NASDAQ: ONCY) (TSX: ONC) reported that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to pelareorep in combination with Roche’s anti-PD-L1 checkpoint inhibitor atezolizumab, and the chemotherapeutic agents gemcitabine and nab-paclitaxel, for the treatment of advanced/metastatic pancreatic ductal adenocarcinoma (PDAC) (Press release, Oncolytics Biotech, DEC 1, 2022, View Source [SID1234624681]). This represents pelareorep’s second FDA Fast Track designation.

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"Receiving this Fast Track designation is an important accomplishment that speaks to the impressive response rate and the durability of the response in our PDAC study, and it also reflects the pressing need to improve upon the standard of care in this indication," stated Dr. Matt Coffey, President and Chief Executive Officer of Oncolytics Biotech Inc. "We expect the opportunity for more frequent communication about our data with FDA provided by this designation will be invaluable as we work to align with the Agency on the best design for a registrational PDAC study. With our core programs in breast and pancreatic cancer both nearing pivotal trials, and eligible for the Fast Track program’s numerous benefits, we believe we are at a crucial point in Oncolytics’ evolution and are excited for what’s ahead."

In November 2022, at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) 37th Annual Meeting, Oncolytics reported interim clinical data showing a 69% objective response rate (ORR) including a complete response (n=13) in a cohort of first-line advanced/metastatic PDAC patients treated with the combination of pelareorep, atezolizumab, gemcitabine, and nab-paclitaxel in the Company’s phase 1/2 GOBLET study. This ORR is nearly triple the average ORR of ~25% reported in historical control trials evaluating gemcitabine in combination with nab-paclitaxel in pancreatic cancer1-4.

Fast Track designation is designed to facilitate the development and expedite the review of therapies to treat serious conditions and fill an unmet medical need. For conditions where an available treatment exists, a therapy must show some advantage over the available treatment, such as superior effectiveness, to be granted a Fast Track designation. A clinical program that receives Fast Track designation may benefit from more frequent meetings and communications with the FDA to discuss development plans and ensure the collection of appropriate data needed to support approval. In addition, clinical programs with Fast Track designation may be eligible for Accelerated Approval and Priority Review, if relevant criteria are met.

References
1. Von Hoff D et al. N Engl J Med 2013; 369:1691-1703 DOI: 10.1056/NEJMoa1304369
2. O’Reilly et al. Eur J Cancer. 2020 June; 132: 112–121. DOI:10.1016/j.ejca.2020.03.005
3. Karasic et al. JAMA Oncol. 2019 Jul 1; 5(7):993-998. DOI: 10.1001/jamaoncol.2019.0684
4. Tempero et al. Ann Oncol. 2021 May; 32(5):600-608. DOI: 10.1016/j.annonc.2021.01.070

On November 29, 2022 Theralink Technologies, Inc. (OTC:THER) ("Theralink" or the "Company"), a precision oncology company with a novel phosphoprotein-based assay for breast cancer, reported that it has entered into definitive agreements with certain institutional and accredited investors for the sale of senior secured convertible debentures and warrants to purchase shares of the Company’s common stock, resulting in total gross proceeds of approximately $3.1 million before deducting the placement agent’s fees and other offering expenses (Press release, Theralink Technologies, DEC 1, 2022, View Source [SID1234624680]).

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Under the terms of the securities purchase agreement, the Company has agreed to sell senior secured convertible debentures, with a principal amount of approximately $3.4 million (including OID of 10%), with a 12-month term. The debentures bear an interest rate of 10% per annum and, upon a qualified financing, will be converted into either (a) the securities sold by the Company in such qualified financing, at a price per share equal to the lesser of $0.003 per share or a 30% discount to the price of securities sold in such qualified financing, or (b) newly issued convertible preferred securities, at a price per share equal to the price described in the foregoing clause (a) or the 5-day VWAP on the 181st day following such exchange, subject to a partial redemption right at the time of the qualified offering. The warrants, calculated at 100% of the principal amount of the debentures, are exercisable upon the earlier of the maturity date of the debentures or a qualified financing at an exercise price equal to the price of the securities sold in such qualified financing or, if no qualified financing has occurred prior to the maturity date of the debentures, the lower of $0.003 per share or 70% of the 10-day VWAP prior to such maturity date.

Additionally, in connection with this offering, holders of certain existing convertible notes and convertible preferred shares of the Company agreed to convert their securities into an aggregate of approximately $13.4 million of the senior secured convertible debentures and warrants on the terms described in the foregoing paragraph.

Joseph Gunnar & Co., LLC is acting as the sole placement agent for the offering.

The convertible debentures and warrants (and shares of common stock underlying the convertible debentures and warrants) described above were offered in a private placement and have not been registered under the Securities Act of 1933, as amended, and may not be offered or sold in the United States absent registration with the Securities and Exchange Commission (the "SEC") or an applicable exemption from such registration requirements. The securities were offered only to accredited investors. Pursuant to the securities purchase agreement entered into with the investors, the Company has agreed to use its commercially reasonable efforts to file a registration statement with the SEC upon the closing of the qualified financing covering the resale of the shares of common stock underlying the convertible debentures and the shares issuable upon exercise of the warrants.

This press release shall not constitute an offer to sell or the solicitation of an offer to buy any of the securities described herein, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.