– Confirmed partial response observed in a patient in the first cohort of patients with metastatic castration-resistant prostate cancer (mCRPC) treated with BPX-601 –

– Favorable safety profile observed in the initial dose cohort of BPX-603 in HER2 + solid tumors –

– Funding is expected to extend the treasury track until mid-2023 and will be used to fund ongoing GoCAR-T clinical development programs –

HOUSTON, December 06, 2021 (GLOBE NEWSWIRE) – Bellicum Pharmaceuticals Inc. (Nasdaq: BLCM), a leader in the development of novel controllable cellular immunotherapies for cancer, today announced positive interim data from its Phase 1/2 GoCAR-T ongoing clinical trials, including partial response (PR) confirmed in the first cohort of mCRPC patients treated in the clinical trial for BPX-601. Bellicum also entered into an agreement for a private placement of $ 35 million in equity securities with two investment funds specializing in biotechnology. Proceeds from the funding will be used to support the ongoing clinical development of BPX-601 and BPX-603.

“We are strongly encouraged by the observation of the anti-tumor activity of BPX-601 in the first mCRPC cohort, particularly in this population of heavily pretreated patients with limited treatment options,” said Rick Fair, President and Chief from the management of Bellicum. “The additional capital that we have raised through this private placement will support our ongoing clinical development of BPX-601 and BPX-603 in order to pursue this early efficacy signal. “

Clinical trial updates

BPX-601 GoCAR-T^® in metastatic castration-resistant prostate cancer
Cellular dose escalation and optimization of the lymphodepletion regimen have been completed in the Phase 1/2 clinical trial of BPX-601 in patients with metastatic pancreatic cancer. Earlier this year, recruitment was initiated in mCRPC patients previously treated at the previously authorized dose level.

In the first cohort of three mCRPC patients treated at 5×10⁶ BPX-601 cells / kg followed by a single dose of rimiducid:

• No dose limiting toxicity was observed. Adverse events were comparable to those previously seen with BPX-601 and rimiducid in metastatic pancreatic cancer and typical of other cell therapy regimens.
• A confirmed partial response was observed in one patient according to RECIST v1.1 computed tomography criteria, accompanied by a substantial reduction in PSA in response to treatment with BPX-601 and rimiducid.

Recruitment is underway in the second dose cohort in the 5×10 mCRPC⁶ cells / kg followed by weekly rimiducid, and results from these patients will be submitted for presentation at a medical meeting in 2022.

BPX-603 Dual Switch GoCAR-T in HER2 + Solid Tumors
Recruitment is underway in the Phase 1/2 clinical trial of BPX-603 in patients with solid tumors expressing human epidermal growth factor 2 (HER2), including breast, endometrial, cancer, cancer. ovary, stomach and colorectal. BPX-603 is Bellicum’s first dual switch GoCAR-T product candidate incorporating iMC activation from Bellicum and CaspaCIDe^® safety switching technologies, which in tandem can be used to improve cell proliferation, persistence and anti-tumor effect while enabling effective management of adverse events.

In the first patients treated in this trial at dose level 1 of 0.1×10⁶ cells / kg BPX-603 alone or followed by weekly rimiducid:

• No dose limiting toxicity was observed.
• Serious adverse events reported were pleural effusion and pneumonia. Neither was determined to be related to the study drug.
• Other grade 3+ adverse events that occurred during treatment were neutropenia, leukopenia, and anemia.
• No CRS or ICANS events were reported.
• Limited cell transplant and expansion has been observed.

Recruitment is underway at dose level 2 of 1×10⁶ cells / kg alone or followed by weekly rimiducid, and results from these patients will be submitted for presentation at a medical meeting in 2022.

According to Charity Writing, PharmD, Business Development Director of Bellicum, “The early clinical activity we observed with BPX-601 in mCRPC and the manageable safety profiles seen in both studies are very encouraging. Based on the very low starting cell dose in the BPX-603 trial, the lack of clinical efficacy at dose level 1 was as expected. I am delighted to join Bellicum full time at such an exciting time in the development of our programs. We look forward to continued dose escalation to further assess the safety and potential efficacy of these product candidates. “

Private placement completed

Bellicum will issue, under the private placement, pre-funded warrants to purchase up to 20,559,210 common shares and associated warrants to purchase up to 2,055,920 common shares. Each pre-funded warrant to purchase common shares is sold together with one warrant to purchase one-tenth of a common share at a combined unit price of $ 1.7024. The common share purchase warrants will be exercisable immediately at an exercise price of $ 1.69 per common share and will expire seven years after the date of issue. Each pre-funded warrant will have an exercise price of $ 0.0001 per share and will be exercisable immediately.

The overall size of the Offer, before the deduction of Selling Agent’s commissions and other offering fees, is expected to be approximately $ 35.0 million, excluding any proceeds that may be received on the Offer. the exercise of ordinary warrants. Bellicum expects to use the net proceeds of the offering, along with its existing capital resources, to fund ongoing and planned clinical trials on BPX-601 and BPX-603, and for general corporate purposes. , including research and development and to finance working capital.

In conjunction with the equity financing announced today, holders of the option to purchase securities associated with Bellicum’s August 2019 private placement have waived, in full, their rights to exercise their right to purchase Series 2 preferred shares and associated warrants, and Series 3 preferred shares and associated warrants, respectively.

Mr. Fair added, “We are delighted that funding support is announced today. The waiver of the rights to exercise the Series 2 and Series 3 options is also a positive step in simplifying our capital structure.

The private placement is expected to close on December 7, 2021. A current report on Form 8-K containing more detailed information regarding the funding will be filed with the Securities and Exchange Commission.

MTS Securities, LLC, a subsidiary of MTS Health Partners, LP, acts as the exclusive placement agent in the funding.

The securities issued or to be issued to buyers under the offer announced today, subject to closing, have been or will be issued, as the case may be, pursuant to an exemption from registration under the Securities Act of 1933 (the “Securities Act”). The securities have not been and will not be registered under the Securities Act or the securities laws of any state or other jurisdiction and may not be offered or sold in the United States absent ‘registration or an applicable exemption from the registration requirements of the Securities Act and the applicable state. or the securities laws of another jurisdiction.

This press release does not constitute an offer to sell or the solicitation of an offer to buy the Securities or any other security, and there will be no offer, solicitation or sale of the Securities or any other security in a State or other jurisdiction in which such offering, solicitation or sale would be illegal.

About Bellicum Pharmaceuticals

Bellicum is a clinical-stage biopharmaceutical company that strives to provide treatments through controllable cell therapy. The Company’s next-generation product candidates feature powerful cell signaling technologies designed to produce more effective CAR-T cell therapies. Bellicum GoCAR-T^® The product candidates, BPX-601 and BPX-603, are designed to be more effective CAR-T cellular products capable of neutralizing the main mechanisms of immune inhibition. You can find more information about Bellicum at www.bellicum.com or follow us on Twitter Where LinkedIn.

Forward-looking statements

This press release contains forward-looking statements for the purposes of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Bellicum may, in certain circumstances, use terms such as “predict”, “believe”, “potential”, “proposed” , “” continue “,” designed “,” estimate “,” foresee “,” expect “,” foresee “,” intend “,” could “,” could “,” could “,” will do “,” should “or other terms that convey uncertainty of future events or results to identify such forward-looking statements. Forward-looking statements include statements regarding intentions, beliefs, projections, prospects, analyzes or Bellicum’s current expectations regarding, among other things: the timing of interim clinical trial results for Bellicum; Bellicum’s plans for the continued clinical development of BPX-601 and BPX-603; the planned closing of the private placement; and l ‘intended use of p product of the supply and the planned cash flow track of Bellicum. Various factors may cause Bellicum’s expectations to differ from actual results, as discussed in more detail under “Risk Factors” in the documents filed by Bellicum with the Securities and Exchange Commission, including, but not limited to. limit, Bellicum’s quarterly report on Form 10-Q for the three months ended September. 30, 2021 and Bellicum’s annual report on Form 10-K for the year ended December 31, 2020. All forward-looking statements made by Bellicum in this press release speak only as of the date of this press release. . Bellicum assumes no obligation to update any forward-looking statements of Bellicum, whether as a result of new information, future events or otherwise, after the date of this press release.

Investors:
Robert H. Uhl
General manager
Westwicke RIC
858-356-5932
[email protected]